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Artemether-lumefantrine Resistance Monitoring in Children With Uncomplicated Plasmodium Falciparum Malaria in Mali

National Institute of Allergy and Infectious Diseases (NIAID) · 2016
ClinicalTrials.gov · Datasets · License: Public Domain · 2016
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Background: Malaria is a disease caused by a parasite. People get malaria if they are bitten by an parasite-infected mosquito. A drug called artemether-lumefantrine (AL) can treat malaria. Although iAL has helped make the malaria problem less severe in the African country of Mali, researchers want to find out if malaria parasites are becoming resistant to this drug. Objective: To test for AL-resistant parasites in children with malaria in Mali. Eligibility: AL resistance monitoring study: children aged 2 17 years who live in Kenieroba, Mali, and have malaria. Blood collection substudy: healthy volunteers aged 18 65 years. Design: Volunteers for the substudy will have blood taken up to 6 times a year. Study participants will be screened with 1 finger-prick blood sample. Girls may have a pregnancy test. Baseline visit: Participants will have a physical exam. Their vital signs and temperature will be measured. They will answer questions about their symptoms. They will give a blood sample. Participants will get 6 doses of AL over 3 days. They will take it in tablet form with milk. Some participants will also stay at the clinic for 2 days. They will have a catheter placed in a vein. They will have blood taken frequently. Participants will have follow-up visits for about 1 month. They may have: Physical exam performed Vital signs and temperature measured Symptom questionnaire administered Finger-prick blood sample and/or a regular blood sample taken Pregnancy test given Antimalarial medications other than AL provided.
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